HPLC同时测定复方盐酸丁卡因凝胶中盐酸丁卡因和乳酸依沙吖啶的含量

Simultaneous Determination of Tetracaine Hydrochloride and Ethacridine Lactate in Oral Cavity Ulcer Gel by HPLC

关键词:  复方盐酸丁卡因凝胶  盐酸丁卡因  乳酸依沙吖啶  含量测定  高效液相色谱法

Key words:  Oral Cavity Ulcer Gel  tetracaine hydrochloride  ethacridine lactate  content determination  HPLC

摘要:

目的 建立高效液相色谱法同时测定复方盐酸丁卡因凝胶中有效成分盐酸丁卡因、乳酸依沙吖啶含量的方法。方法 采用Thermo Hypersil BDS C₁₈色谱柱(4.6 mm×150 mm，5 μm)，以乙腈-水-三乙胺(30∶70∶0.5)为流动相，双通道检测波长为270 nm和310 nm，流速为1 mL·min^-1，进样量为10 μL。结果 盐酸丁卡因在40.0~160.0 mg·L^-1内峰面积与浓度呈良好的线性关系(r=0.999 9)，平均回收率为100.2%，RSD为2.08%；乳酸依沙吖啶在38.1~152.4 mg·L^-1内峰面积与浓度呈良好的线性关系(r=0.999 8)，平均回收率为99.7%，RSD为1.71%。结论 本法简便、准确、重复性好，可用于复方盐酸丁卡因凝胶中盐酸丁卡因和乳酸依沙吖啶的含量测定。

Abstract:

OBJECTIVE To establish an HPLC method for simultaneous determination of tetracaine hydrochloride and ethacridine lactate in oral cavity ulcer gel. METHODS The column of Thermo Hypersil BDS C₁₈(4.6 mm×150 mm, 5 μm) was used, the mobile phase was a mixture of acetontrile-water-triethylamine (30∶70∶0.5), UV detector was set to double detection wavelength, the detection wavelength was 270 nm and 310 nm for tetracaine hydrochloride and ethacridine lactate, respectively; the flow rate was 1 mL·min^-1, and the injection volume was 10 μL. RESULTS The linear range of tetracaine hydrochloride was 40.0-160.0 mg·L^-1(r=0.999?9), and the average recovery was 100.2%, RSD=2.08%. The linear range of ethacridine lactate was 38.1-152.4 mg·L^-1(r=0.999 8), and the average recovery was 99.7%, RSD=1.71%. CONCLUSION The method is simple, accurate, reproducible, and suitable for the simultaneous determination of tetracaine hydrochloride and ethacridine lactate in oral cavity ulcer gel.